This is an open-label, multi-centre, randomised Phase III study, looking at a series of 480 patients up to the age of 65 with newly diagnosed multiple myeloma (MM) not previously treated. They will receive VAD or Velcade®/dexamethasone combination as induction treatment plus/minus (±) dexamethasone/cyclophosphamide/etoposide/cisplatin (DCEP) followed by autograft as first-line therapy, as the investigators try to compare the complete remission (CR) rate (with negative or positive immunofixation) at the end of their induction treatment.

To compare the CR rate (with negative or positive immunofixation) obtained with VAD or the Velcade®/dexamethasone combination used as induction treatment in patients up to the age of 65 with newly diagnosed MM, at the end of this induction treatment

Recently diagnosed MM according to the criteria of the South West Oncology Group (SWOG)

Not previously treated, apart from local radiotherapy, in the case of a threatening or incapacitating lesion, and/or a 4-day block of dexamethasone (40 mg/mL) in an emergency

Stage II or III disease according to the Durie and Salmon classification or Stage I disease with symptomatic bone lesion

< 65 years of age

Ability to give signed informed consent

Secretion of a measurable monoclonal spike (> 10 g/l in the serum or 0.2 g/24h in the urine)

Negative pregnancy test at inclusion (if necessary)

Absence of active infection. In the case of infection, appropriate antibiotic therapy must be administered and patients must have been apyretic for 48 hours before the start of treatment with VAD or Velcade®/dexamethasone

Exclusion Criteria:

ECOG performance status > 2

History of cancer (other than basal cell carcinoma or carcinoma of the cervix in situ)

Use of an investigational medicinal product during the 30 days prior to inclusion

Known hypersensitivity to bortezomib, boron or mannitol

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00200681